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AstraZeneca (AZN) COVID-19 Jab May Have Link to Rare Blood Clots

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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) found a “possible link” between AstraZeneca’s (AZN - Free Report) COVID-19 vaccine and extremely rare blood clotting issues in the brain in adults who had received the shot.

AstraZeneca issued a statement, which said that the regulatory agencies have completed their latest review from over 34 million people vaccinated with AstraZeneca’s jab in the United Kingdom and EU and have requested updating UK and EU labels for the vaccine. The agencies, however, could not identify any definite cause for such blood clot events, which are occurring alongside low levels of platelets.

Meanwhile, The World Health Organization (WHO) said that a “casual relationship” between the vaccine and blood clot risk factors events is probable. However, “specialized studies” will be required to confirm such a relationship. However, WHO said such events are rare and very few numbers have been reported among the 200 million individuals vaccinated with AstraZeneca’s jab.

The MHRA maintained that the benefits of vaccination continue to outweigh any risks. However, the incidence of blood clot events was higher in younger adult age groups, the MHRA concluded, a fact which should be taken into account while considering usage of the vaccine. Meanwhile. U.K’s Joint Committee on Vaccination and Immunisation (JCVI) recommended that individuals below 30 years of age should opt for an alternative vaccine available in the country. At present, Pfizer (PFE - Free Report) -BioNTech’s (BNTX - Free Report) BNT162b2 and Moderna’s (MRNA - Free Report) mRNA-1273 vaccines are available in Britain.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended to list the unusual blood clots with low blood platelets as a rare side effect of the vaccine. However, the committee still said that the vaccine’s benefits outweighed the risks.

The MHRA had received 79 reports of blood clotting cases in the United Kingdom up to  Mar 31, all of which occurred after the first dose of the vaccine. The MHRA recommended that those who did not experience any such side effect after the first dose should not hesitate to get the second shot. The JCVI said there were no reports of such thrombosis/thrombocytopenia events in any individual who had received the second dose of the vaccine.

AstraZeneca’s shares were down 1.6% on Wednesday. This year so far, AstraZeneca’s shares have declined 3.2% compared with a decrease of 1% for the industry.

 

 

Earlier this week, The University of Oxford reportedly paused dosing in a small U.K. study, evaluating AstraZeneca’s COVID-19 vaccine in children and teenagers after fresh             concerns about rare blood clot issues and pending reviews by regulators in the U.K. and European Union. It remains to be seen whether the university resumes dosing in the study in children since the regulators have completed their reviews and given their opinions.

AstraZeneca’s vaccine has been surrounded by controversies and negative reports for some time now.

In March, many European countries, including Germany, France and Italy, temporarily paused vaccinations with AstraZeneca’s jab following some reports of blood clots in people who had received the shot. However, the PRAC, back then, concluded there was no increase in the overall risk of blood clots with the use of AstraZeneca’s vaccine. Germany, France, Italy and some other European nations later resumed using AstraZeneca's COVID-19 vaccine after EMA’s report. Some countries however restricted its use in younger people.

In March, the National Institutes of Health’s (NIH) Data Safety Monitoring Board (DSMB) doubted that the late-stage data released by AstraZeneca from a large-scale U.S. study on its COVID-19 vaccine may have included “outdated” information. The outdated information, as a result, may have provided an incomplete picture of the efficacy data, the statement released by the DSMB said.

The DSMB’s statement was released just hours after AstraZeneca announced interim data from a U.S. late-stage study on its vaccine candidate, AZD1222, which showed that the candidate was, on average, about 79% effective in preventing COVID-19. Later the company updated the data to show that the vaccine was about 76% effective against symptomatic COVID-19.

AstraZeneca’s vaccine is approved for temporary/conditional use in more than 50 countries including the European Union. However, it has not yet received authorization from the FDA.

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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